CTRI/2024/03/064225
Not yet recruiting
Phase 2
Clinical validation of safety and effectiveness of Zipitrit skin cream (Batch No. ZP-01) in the management of skin fungal infection and eczema. - NI
M. N. Pharmaceuticals0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: L20-L30- Dermatitis and eczema
- Sponsor
- M. N. Pharmaceuticals
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age group between 18 to 65 years old, both inclusive
- •2\. Confirmed diagnosis of skin fungal infection
- •3\. No systemic antifungal treatment within the previous two weeks
- •4\. No use of topical antifungal agents within the previous seven days
- •5\. No history of allergy to components of the study medication
- •6\. Subjects ready to take injection TT before application of study drug
- •Inclusion criteria for eczema:
- •1\. Patients of either sex in the age group between 18 to 65 years both inclusive;
- •2\. IGA score of 2 or 3 (mild or moderate) during screening and baseline;
- •3\. BSA of AD involvement of 4\-12%;
Exclusion Criteria
- •1\. Pregnant or lactating women or women of child bearing positive urine pregnancy test at screening. All subjects agree to use an adequate contraceptive method throughout the study;
- •2\. Use of biologic therapy within 12 weeks;
- •3\. Regular use of tanning booth within 4 weeks;
- •4\. Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with study assessments;
- •5\. Any other comorbid condition which is not on stable prescription for last 3 months.
- •6\. Subjects who are using any concomitant medications that in the investigators opinion, could affect the subjects atopic dermatitis (e.g. Antihistamines) Subjects using such medications and have been stable on treatment for at least one month prior to visit 2 (Day 1 of IP) and no changes to these medications are planned during study may be included in the study at the investigators discretion;
- •7\. Abnormal renal function (defined as serum creatinine more than 1\.5xULN) or abnormal liver function (defined as any transaminases more than 2xULN);
- •8\. Known hypersensitivity to any of the components of the study drug;
- •9\. Known or suspected history of alcohol or drug abuse;
- •10\. Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history;
Outcomes
Primary Outcomes
Not specified
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